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Regeneron/Sanofi's Libtayo Gets EU Approval for Skin Cancer

Zacks Equity Research

Regeneron Pharmaceuticals, Inc. REGN and partner Sanofi SNY announced that the European Commission (EC) has granted conditional marketing authorization to skin cancer drug, Libtayo.

The drug, which is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 (programmed cell death protein-1), has been approved in the European Union for the treatment of adults with metastatic or locally-advanced cutaneous squamous cell carcinoma (CSCC), who are not candidates for curative surgery or curative radiation.

The EU approval is based on data from the pivotal, open-label, multi-center, non-randomized phase II study known as EMPOWER-CSCC-1 (Study 1540) and supported by two advanced CSCC expansion cohorts from a multi-center, open-label, non-randomized phase I study (Study 1423).

Since the drug has been granted conditional approval, Regeneron and Sanofi will add a new patient group to EMPOWER-CSCC-1 to support the benefit-risk profile of Libtayo. Thereafter, the companies will submit the results to the European Medicines Agency (EMA) for a label update.

We note that Libtayo is already approved in the United States, Canada and Brazil for adult patients with metastatic or locally-advanced CSCC, who are not candidates for curative surgery or curative radiation.

The initial uptake of the drug is strong. Approval in other countries will further boost sales. CSCC is one of the most commonly diagnosed skin cancers worldwide and prevalent in some European countries.

Meanwhile, Libtayo is being evaluated in adjuvant and neoadjuvant trials in CSCC, and potential registrational trials in non-small cell lung cancer, basal cell carcinoma and cervical cancer. Additional studies include trials in squamous cell carcinoma of the head and neck, melanoma, colorectal cancer, prostate cancer, multiple myeloma, Hodgkin's lymphoma and non-Hodgkin's lymphoma.

We are impressed with Regeneron’s efforts to bring new drugs to the market and concurrently expand the label of key drugs — Eylea and Dupixent.  The FDA has approved a label expansion of asthma drug, Dupixent. The drug is now approved for use with other medicines to treat chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults, whose disease is not controlled. The company is working to expand the drug’s label further into several other indications.

Label expansion of certain drugs will diversify the company’s revenue base and reduce dependence on lead drug, Eylea.

Regeneron’s stock has lost 15.3% in the year so far against the industry’s growth of 7%.


The company has a deep pipeline, including fully human monoclonal antibodies generated using the VelocIimune technology. Promising candidates in the pipeline include fasinumab, among others, which is being developed in collaboration with Teva Pharmaceuticals TEVA.

Zacks Rank & A Stock to Consider

Regeneron currently carries a Zacks Rank #3 (Hold).

A better-ranked stock in the same space is Gilead Sciences, Inc. GILD, which carries a Zacks Rank #2 (Buy) currently.  You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Gilead’s earnings estimates have moved up 15 cents to $6.89 for 2019 over the past 60 days.

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